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FDA 510(k)

cryoICE cryoXT cryoablation probe (cryoXT)

K-Number: K250371 · 2025-04-10

ApplicantAtriCure, Inc.
Decision Date2025-04-10
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

cryoICE cryoXT cryoablation probe (cryoXT) is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2025-04-10 under approval number K250371. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cryoICE cryoXT cryoablation probe (cryoXT)?

cryoICE cryoXT cryoablation probe (cryoXT) is a medical device that received FDA 510(k) clearance on 2025-04-10. It is manufactured by AtriCure, Inc.. The 510(k) number is K250371.

When was cryoICE cryoXT cryoablation probe (cryoXT) approved by the FDA?

cryoICE cryoXT cryoablation probe (cryoXT) received FDA 510(k) clearance on 2025-04-10, under approval number K250371.

What company makes cryoICE cryoXT cryoablation probe (cryoXT)?

cryoICE cryoXT cryoablation probe (cryoXT) is manufactured by AtriCure, Inc..

What is the FDA product code for cryoICE cryoXT cryoablation probe (cryoXT)?

The FDA product code for cryoICE cryoXT cryoablation probe (cryoXT) is GXH.

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Related Devices (Code: GXH)

K161835iovera systemMyoscience, Inc. K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. K173763iovera systemMyoscience, Inc. K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc. K211334Iovera SystemPacira Pharmaceuticals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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